In a new report released this week, the International Alliance of Dietary/Food Supplement Associations (IADSA) urged regulators and national scientific agencies to look beyond the narrow view of valid nutrition science that has for the past few years been championed by the likes of the European Food Safety Authority (EFSA), to incorporate the ‘totality of evidence’ available for any particular nutrient.
“Unlike drugs, bioactive substances pose minimal risks when consumed in the nutritional range, and provide evidence for efficacy from a totality of evidence beyond the prospective randomized controlled trials (RCT),” said one of the report authors, Dr Andrew Shao, who works in regulatory affairs at Herbalife and sits on the IADSA Scientific Group.
“Often they have less marked acute effects which are not apparent or cannot be tested using the RCT. It is not surprising that such an approach often fails to detect any benefit of bioactive substances even when there has been considerable evidence published in the peer-reviewed scientific literature in cell culture, animal models and humans.”
In fact, it can be argued that this EBM approach should be reconsidered as a way of evaluating the potential health benefits of bioactive substances.”
Dr Shao wrote the report, titled, ‘Bioactive Food Components: Changing the Scientific Basis for Intake Recommendations’, with Dr David Heber from the Centre for Human Nutrition at the David Geffen School of Medicine, University of California. It is freely available to download from the IADSA website.
It says smaller intervention trials than those typically used in drug trials are needed along with increased post-surveillance for any potential adverse events.
Other suggestions include:
- evidence on the chemical composition;
- studies showing the biological underpinning of proposed health benefits in appropriate cell culture and animal models;
- information on the bioavailability, site of action, absorption and metabolism of the bioactive substance or mixture.
Dr Shao added: “There is clearly a need to develop a scientific framework to communicate the potential benefits of bioactive substances to the public that establishes reasonable certainty of benefits while also providing assurance of safety…and all scientifically valid evidence of biological effects supporting health benefits based on observations in cell culture, animal models, and in human populations and intervention trials should be considered as a whole in making recommendations for the intake of bioactive substances.”